FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXLE INTERSPINOUS FUSION SYSTEM
K Number: K130438
·
Decision Jun 27, 2013
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
47
Applicant Total
34
Review Days
126
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Basic Information
- Device Name
- AXLE INTERSPINOUS FUSION SYSTEM
- K Number
- K130438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- X-Spine Systems, Inc.
- Date Received
- February 21, 2013
- Decision Date
- June 27, 2013
- Product Code
- PEK
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PEK | Spinous Process Plate | FDA class 2 | Orthopedic |
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Other Clearances by X-Spine Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K173832 | InTice-C Porous Ti Cervical Interbody System | May 17, 2018 | Substantially Equivalent |
| K180153 | X-spine Cortical Bone Screw System | Mar 15, 2018 | Substantially Equivalent |
| K170119 | Calix Lumbar Spinal Implant System | Sep 29, 2017 | Substantially Equivalent |
| K171567 | IRIX-A Lumbar Integrated Fusion System | Aug 28, 2017 | Substantially Equivalent |
| K171075 | Calix-C Cervical Interbody Spacer | Aug 1, 2017 | Substantially Equivalent |
| K170224 | Spider Cervical Plating System | Jul 6, 2017 | Substantially Equivalent |
| K170530 | Butrex Lumbar Buttress Plating System | Mar 22, 2017 | Substantially Equivalent |
| K160959 | Xsert Lumbar Expandable Interbody System | Nov 17, 2016 | Substantially Equivalent |
| K162944 | Irix-C Cervical Integrated Fusion System | Nov 7, 2016 | Substantially Equivalent |
| K160428 | Certex Spinal Fixation System | May 5, 2016 | Substantially Equivalent |